A Prospective Clinical Study on the Efficacy and Safety of Bacterial Lysate (OM-85) Combined With Antihistamines in the Treatment of Chronic Spontaneous Urticaria (CSU): A Single-Centre, Observational, Cohort Study

NCT07557888 | Not Yet Recruiting

• 1 other identifier: KY-2026-081
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

A Prospective Clinical Study on the Efficacy and Safety of Bacterial Lysate (OM-85) Combined with Antihistamines in the Treatment of Chronic Spontaneous Urticaria (CSU): A Single-Centre, Observational, Cohort Study

Conditions

Chronic Spontaneous Urticaria (CSU)

Outcome Measures

Primary Outcomes (1)

• UAS7 score at week 12 of treatment (90 days)

  Assessed using the 7-day Urticaria Activity Score (UAS7), compared with baseline

  From baseline to weeks 4, 8, and 12

Secondary Outcomes (3)

• Proportion of subjects with UAS7 ≤ 6 at week 12 of treatment (disease well controlled)

  Week 12 (90 days)

• Changes in the CU-Q2oL score

  From baseline to week 12

• Proportion of subjects with UCT ≥ 12 at week 12 of treatment

  From baseline to weeks 4, 8, and 12

Study Arms (2)

Exposure group

Bacterial lysate capsules + second-generation antihistamines (loratadine tablets, cetirizine hydrochloride tablets, levocetirizine hydrochloride tablets, ebastine tablets, olopatadine hydrochloride tablets, fexofenadine hydrochloride tablets)

Non-exposure group

Second-generation antihistamines (loratadine tablets, cetirizine hydrochloride tablets, levocetirizine hydrochloride tablets, ebastine tablets, olopatadine hydrochloride tablets, fexofenadine hydrochloride tablets)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The inclusion and exclusion criteria for the study participants are as set out above

You may qualify if:

• The participants were fully informed of the purpose, procedure and risks of the study and voluntarily signed the informed consent form.
• Aged 18 to 65 (inclusive), no gender restrictions.
• Meets the CSU diagnostic criteria, with a disease duration of ≥6 weeks.
• Antihistamine resistance: Regular use of a standard dose (as recommended in the package leaflet) of a second-generation H1 antihistamine (e.g. desloratadine 5 mg, levocetirizine 5 mg, etc.) for at least 2 weeks prior to screening, but with symptoms still not effectively controlled. Defined as: a UAS7 score of ≥7 within 7 days prior to the screening visit (V1) and baseline visit (V2).
• Agree to maintain the type and dose of the baseline antihistamine throughout the trial.
• Agree not to consume any products that may significantly affect the gut microbiota during the trial (such as yoghurt containing probiotics, or probiotic/prebiotic supplements).
• At the baseline visit, the treatment regimen was clearly defined, and exposure status (OM-85 exposure group or non-exposure group) could be determined based on actual prescriptions and medication records.

You may not qualify if:

• Special types of urticaria: These primarily include physical urticaria (such as artificial urticaria, cold contact urticaria and cholinergic urticaria), urticarial vasculitis, and angioedema caused by hereditary or acquired C1 esterase inhibitor deficiency;
• Systemic use of glucocorticoids (oral or injectable) within the four weeks prior to screening;
• Exclude patients who have used immunosuppressants (such as cyclosporine, methotrexate, or Tripterygium wilfordii) within the previous four weeks;
• Exclude patients who have used biologics (such as omazulimab, dupilumab, etc.) within the previous three months;
• Exclude those who have used bacterial lysates (such as Panfuxu or Pidomod) or received vaccinations within the past three months;
• Patients with severe systemic autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.) may interfere with the assessment of immune mechanisms;
• A history of serious liver, kidney, heart, lung or blood disorders, or malignant tumours;
• Individuals known to be allergic to bacterial lysates and their excipients.
• Special populations: pregnant or breastfeeding women, or participants of childbearing age who do not intend to use contraception during the trial.
• Other: Participants who have taken part in other clinical trials involving medicinal products within the past 30 days; or where the investigator considers that there is poor compliance, a mental health condition, or any other circumstance rendering the participant unsuitable for the trial.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liu

CONTACT

0579-89979999; 2197055@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CN (1)